Bioventus reiterates 2026 guidance after FDA device reclassification

Bioventus Inc. (NASDAQ: BVS) said it expects to maintain its 2026 financial guidance following regulatory changes affecting its bone healing device.

The U.S. Food and Drug Administration issued a final order on April 16, 2026, reclassifying non-invasive bone growth stimulators from Class III to Class II devices. The reclassification affects Bioventus's Exogen Ultrasound Bone Healing System along with similar devices.

Following the FDA reclassification, the Centers for Medicare & Medicaid Services updated billing requirements and Medicare fee schedules for non-invasive bone growth stimulators. The changes apply to devices billed under HCPCS codes E0747, E0748, and E0760 for services provided on or after May 18, 2026.

The company stated it does not expect the reimbursement rate changes for its Exogen device to materially impact its fiscal year 2026 financial results. The medical device company reiterated its previously issued financial guidance for 2026.

Bioventus noted it will continue evaluating potential long-term impacts of current and future CMS actions. The company said additional changes to Medicare reimbursement rates for the Exogen device could require revisions to its financial outlook.

The information was disclosed in a company statement.

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